Transient Phenotypes are Patent Eligible

Transient Phenotypes are Patent Eligible

I am very happy for our client, UAS Labs, for winning their appeal of, among other things, rejection for patent ineligibility under 35 U.S.C. §101. Ex parte Prakash et al., PTAB Appeal No. 2018-004374. This case presents an interesting question: is a bacterial cell with a transient phenotype that doesn’t result from genetic modification patent eligible? The Patent Trials and Appeal Board (“PTAB”) says yes.

U.S. Patent Application No. 13/111,105 is directed to highly bile salt hydrolase (BSH) active bacteria. The BSH levels are extremely high when compared to natural bacteria. This was achieved not with a BSH transgene, but rather, by inventive culture conditions. The high BSH activity is transient but can be stabilized by certain chemicals. Exemplary claims include:

33. A bile salt hydrolase (BSH) active bacteria, comprising a first BSH activity that results from growth in an optimized plurality of growth medium components, wherein said first BSH activity is between 6.1 and 113.6 fold higher than a second BSH activity that results from the growth of said BSH active bacteria in de Man, Rogosa, Sharpe (MRS) medium.

34. The BSH active bacteria of claim 33, wherein said first BSH activity is between 8.9 and 113.6 fold higher than said second BSH activity.

3. An oral composition, comprising the BSH active bacteria of claim 34; wherein said first BSH activity degrades >2253 µmol glycodeoxycholic acid (GDCA)/gram wet bacterial pellet/hr when measured over 30 minutes, wherein said high BSH activity is stable so that at least about 69.2% of said BSH activity is retained when said highly BSH active bacteria are stored for a time period of at least 3 weeks.

Patent eligibility is governed by 35 U.S.C. §101. Claims directed to only laws of nature, natural phenomena, and abstract ideas are not patentable. This is because claims directed to these “judicial exceptions” would too broadly preempt their use in the relevant arts. The Supreme Court elaborated a two-part test for patent eligibility, the so-called "Mayo Test:" (1) Determine whether the claim recites a judicial exception, and if so, (2) determine whether the claim elements, considered both individually and as an ordered combination, contain something “significantly more than the judicial exception.”

The PTAB first construed the term “[a] bile salt hydrolase (BSH) active bacteria, comprising a first BSH activity that results from growth in an optimized plurality of growth medium components.” In their view, the broadest reasonable interpretation is “a BSH active bacteria grown in an optimized plurality of growth medium components such that it possesses the level of recited ‘first BSH activity’ in the presence of the appropriate substrate
at the time such activity is being measured.” (Opinion at p. 7, emphasis original.)

In applying the Mayo test, the PTAB found that the claimed highly BSH-active bacteria is not a judicial exception to patentability. They found that the claimed bacteria have “markedly different characteristics (
i.e., in the level of BSH activity) from the bacteria found in nature.” (Id. at 10.)

The PTAB also distinguished this case from
In re Roslin Institute (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014). In Roslin, a live-born clone was not patent-eligible. While the cloned sheep, Dolly, had the same genotype as her “parent,” she had a different phenotype. The distinction from this case, however, is that the phenotype came about through her natural environment, not through human ingenuity. The phenotype in this case came about by human ingenuity. (Id. at 10., citing Roslin, 750 F.3d at 1337.)

The Examiner argued that the claims are not patent-eligible because the high BSH activity is transient. The PTAB agreed with the Examiner that “a claim may encompass natural phenomenon and thus be patent-ineligible subject matter if the markedly different characteristic is transient
and if the claim encompasses bacteria that no longer possesses the markedly different characteristic.” (Opinion at 13, emphasis original.) The PTAB was not aware of any authority that a transient characteristic may not be “markedly different” from natural phenomenon so long as the claim is limited to subject matter that possesses the transient characteristic. (Id. at 13.) Under the PTAB’s claim construction, the high BSH activity was markedly different from natural bacteria at the time that it was measured.

(1) Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (U.S. 2012); Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354 (2014).

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